Patients who meet any of the following criteria are NOT eligible for inclusion in the study. 1. Being totally asymptomatic at the screening time, 2. Requires supplemental oxygen therapy or mechanical ventilation, 3. Being already under raloxifene or other SERM treatment for another medical condition at the time of randomization, 4. Being concurrently involved in another trial with IP or participation in any clinical trial with IP for 1 months before this study. The 1-month interval is calculated as the time between the last visit of the previous study and the first day of the present study (date of the informed consent signature), 5. Clinically significant abnormal physical findings which could interfere with the objectives of the study, 6. Diseases: a) history of stroke and/or venous thromboembolism, b) known moderate / severe renal impairment: Chronic Kidney Disease (CKD) stage 3 or higher, c) known liver disease (Child-Pugh Class A or higher), d) presence of known hypoalbuminemia, e) endometrial bleeding, f) signs or symptoms of endometrial cancer, 7. Autoimmune diseases receiving therapy at the time of randomization, 8. Risk of venous thrombosis or any condition/disease that could bring to an extended period of immobilization, 9. Ascertained or presumptive hypersensitivity to the active principles (raloxifene) and/or excipients or allergic reactions in general, which the Investigator considers may affect the outcome of the study, 10. Medications: in particular cholestyramine (or any ion exchange resin), medications used in treatment of early or advanced breast cancer (including adjuvant therapy), warfarin, any drug that cannot be co-administered with the experimental compound, 11. Pregnancy: a) positive or missing pregnancy test before first drug intake or day 1, b) pregnant or lactating women, 12. Women of childbearing potential and fertile men who does not agree to use at least one primary form of contraception for the duration of the study.

Patients who meet any of the following criteria are NOT eligible for inclusion in the study. 1. Being totally asymptomatic at the screening time, 2. Requires supplemental oxygen therapy or mechanical ventilation, 3. Being already under raloxifene or other SERM treatment for another medical condition at the time of randomization, 4. Being concurrently involved in another trial with IP or participation in any clinical trial with IP for 1 months before this study. The 1-month interval is calculated as the time between the last visit of the previous study and the first day of the present study (date of the informed consent signature), 5. Clinically significant abnormal physical findings which could interfere with the objectives of the study, 6. Diseases: a) history of stroke and/or venous thromboembolism, b) known moderate / severe renal impairment: Chronic Kidney Disease (CKD) stage 3 or higher, c) known liver disease (Child-Pugh Class A or higher), d) presence of known hypoalbuminemia, e) endometrial bleeding, f) signs or symptoms of endometrial cancer, 7. Autoimmune diseases receiving therapy at the time of randomization, 8. Risk of venous thrombosis or any condition/disease that could bring to an extended period of immobilization, 9. Ascertained or presumptive hypersensitivity to the active principles (raloxifene) and/or excipients or allergic reactions in general, which the Investigator considers may affect the outcome of the study, 10. Medications: in particular cholestyramine (or any ion exchange resin), medications used in treatment of early or advanced breast cancer (including adjuvant therapy), warfarin, any drug that cannot be co-administered with the experimental compound, 11. Pregnancy: a) positive or missing pregnancy test before first drug intake or day 1, b) pregnant or lactating women, 12. Women of childbearing potential and fertile men who does not agree to use at least one primary form of contraception for the duration of the study.